In May 2022, the EU implemented the new in-vitro medical devices Regulation (IVDR) to ensure the safety and performance of in-vitro diagnostic medical devices. This new regulation became mandatory for all manufacturers placing IVD products on the EU market.
We are excited to announce that ALBA by Quotient, our brand of reagents, has received its first product group certification for the Class C Blood Grouping Reagents. This is a significant first step in recertifying all our products under the new IVDR standards.
The new regulation brings changes such as new product risk classifications, the need for additional performance evaluation data, an increase in third-party controls.